I have published the following commentary on the HealthNewsReview.org website.
TIME magazine, like many publications, loves year-end lists. Its “Top Ten Medical Breakthroughs of 2007”
list offers brief capsules on developments that someone at TIME decided were “in the top ten” and also that someone decided qualified as “breakthroughs.” The list:
• Circumcision can prevent HIV•Test for metastatic breast cancer
•First human vaccine against bird flu
•Help for dieters: Alli
•New diabetes genes
•No more periods (Lybrel)
•Relief from fibromyalgia: Lyrica
•Early-stage test for lung cancer
•New source of stem cells
•Benefits of vitamin D
We believe that with any claim of “breakthrough’” the claimant should include some discussion of the quality of the evidence behind this claim. And for stories that discuss treatments, tests, products or procedures, we should be talking at least a little bit about how much these “breakthroughs” will cost.
TIME didn’t mention cost with any of the ten breakthroughs it highlighted. The magazine didn’t discuss the quality of the evidence behind the ideas covered in any of the eight product-related stories. The discussion of benefits was lacking in several.
Yes, we know that editors think these lists are cute, promotable features. But the cumulative effect of discussing breakthrough after breakthrough without any mention of cost or evidence leaves the reader waiting for Santa to arrive with the next one.
The “Help for dieters: Alli” segment stated that the drug “blocks the body's ability to absorb fat by 30%.” But what does that mean to the user? And given the “common and unpleasant side effects — cramps, gas, diarrhea and oily discharge” that the article acknowledges about the drug, we can only ask: Is this a breakthrough?
We ask the same question about the “No more periods” segment about the drug Lybrel. This is a breakthrough? The story acknowledges that the new pill “is similar to the conventional Pill” but doesn’t mention other competing products on the market that may limit the frequency of a woman’s periods. How do they compare?
The “Relief from fibromyalgia: Lyrica” segment states: “In studies, Lyrica not only soothed the aches of fibromyalgia but also significantly improved patients' quality of life.” How was that measured? How would a reader objectively quantify the chance for benefit? For harms?
For 2008, it is our hope that more news organizations abandon the breakthrough mentality. There aren’t breakthroughs every month as the magazine implies. There are things one stands to gain and things one stands to lose with any treatment, test, product or procedure. Readers need help weighing the evidence. And they certainly need help thinking about health care costs.
We need more informed health care consumers, not more magic bullet believers.
Mark Zweig and Emily DeVoto authored a thoughtful piece on how journalists may imply cause-and-effect in reporting on research, when the study design didn't really establish cause-and-effect. Examples:
Eating fish may help preserve eyesight in older people.The authors calculated that participants who did 75 minutes a day of activities… lowered their risk of dying by 30%...
Overall, those who drank [coffee] were 22 percent less likely to have diabetes, with decaf drinkers reaping somewhat greater benefit…
Women who ate fish 5 times a week cut their risk of dying later from a heart attack by half...
Higher aspirin dose seems to stave off some cancers… The strongest effect was for colon cancer.
Drugs that suppress acids may make fractures more likely…Taking proton pump inhibitors for more than a year increased the likelihood of a hip fracture by 44 percent.
They urge health care journalists to be mindful of when cause-and-effect language is warranted by the study design and when it is not.
Two amusing articles in this week's BMJ.
One tackles questions about medical myths, such as:
Should we drink at least eight glasses of water a day?Does shaving hair cause it to grow back faster or coarser?
Does reading in dim light ruin your eyesight?
Does eating turkey make you especially drowsy?
The other analyzes some of the new slang doctors use, such as:
Hasselhoff: An injury with a bizarre explanation presenting to Accident and Emergency. Named after the former Baywatch actor David Hasselhoff who suffered a freak injury in 2006 when he hit his head on a chandelier while shaving. The broken glass severed four tendons and an artery in his right arm.Testiculation: The holding forth with expressive hand gestures by a consultant on a subject on which he or she has little knowledge.
Blamestorming: A session of mutual recrimination during which a multidisciplinary team attempts to apportion blame for a glaring error.
404 moment: The point in a ward round when - despite searches of the notes or electronic records - a result cannot be found. (From the world wide web error message “404: document not found.”)
Jack Bauer: A doctor still up and working after 24 hours on the job—now something of a rarity but will be recognised by older clinicians.
Ringo: Expendable member of a team. (After Ringo Starr, drummer with the Beatles. John, Paul, and George went on to successful solo careers. Ringo did the voiceover for Thomas the Tank Engine.)
If you're hurting for last-minute stocking-stuffer ideas, you may want to ask a friendly physician for some of his/her leftover pharma fun trinkets. For inspiration, visit the website Drug Rep Toys: The toys and trinkets with which drug companies make themselves known to physicians.
More than a year ago, the publisher of the site started posting pictures of all the Pharma handouts he or his site visitors had received.
On a brief visit, I found:
• a pill counter (helpful reminder to take each and every "me too" drug)
• a calculator (helpful when tabulating one's health premium debt)
• a laser pointer (drives your dog crazy enough that he may need an anti-psychotic)
• a reflex hammer (always wanted one of those in the home toolkit)
• a six-pack tote (for self-medication)
• calipers (for wallet biopsies)
• stress balls (not a new DSM disease entity)
No one posted any pictures of airline tickets to resort settings for a "scientific meeting." I'm shopping for a different such website - perhaps one from a "key opinion leader" who has better stuff in his/her stocking this Christmas.
The Integrity in Science Watch project of the Center for Science in the Public Interest reports:
The investigations subcommittee of the House Energy and Commerce Committee last week gave Schering-Plough and Merck until Christmas to turn over documents from a clinical trial involving the cholesterol-lowering drug Zetia. The New York Times reported last month that the companies had failed to meet last spring's release date for a trial that compared the efficacy of a combination of Zetia and Zocor to Zocor alone. The companies then missed a fall deadline and said they wouldn’t release the data from the 720-person Enhance trial until next spring. They also wanted to change the trial's clinical endpoint, which drew heavy criticism from cardiologists who prescribe the drug. The companies backed off that decision last week and reinstated the original protocols of the trial, according to the Wall Street Journal.The letter, signed by chairman John Dingell (D-MI) and investigations subcommittee chairman Bart Stupak (D-MI), wanted to know why the clinical trial wasn’t registered in the government’s database until 18 months after its completion. Until the recently enacted Food and Drug Administration reform law required registration of most clinical trials prior to their start-up, registration was voluntary. Zetia, whose generic name is ezetimibe, was approved by the Food and Drug Administration in 2002 because it lowered bad (LDL) cholesterol. But, unlike statin drugs, it has never been tested in a clinical trial to show that it actually decreases mortality from heart attacks and strokes. Even the Enhance trial will only measure the drug’s impact on arterial plaque, not if it reduces deaths from heart disease. The drug is sold primarily as part of Vytorin, a pill combining Zetia and Zocor (simvastatin) that has captured 20 percent of the cholesterol-lowering drug market.
John Mack, publisher of Pharma Marketing News, recently wrote an essay worrying about drug industry support of continuing medical education or CME. Excerpts:
"In 2006, commercial support of CME totaled about $1.19 billion ($1.44 billion if you include advertising and exhibits at CME events). That represents about 50% of the total support.Why won’t physicians pay for CME?
Although $1.2 billion is only a small fraction of the total promotional spend of the industry, a billion here, a billion there, and pretty soon we’re talking about real money! Why should pharma contribute so much for CME in the first place? Doesn’t that naturally lead to biased content? Shouldn’t there be a ban on commercially-funded accredited CME? Why can’t physicians pay for their CME like many other professionals do?"
Congressional Budget Office director Peter Orszag gave his long-term budget outlook to a congressional budget committee this week.
For anyone with a pulse, there was nothing surprising in the report:
"...rising costs for health care and the aging of the U.S. population will cause federal spending to grow rapidly. If federal revenues as a share of gross domestic product (GDP) remain at their current level, that rise in spending will eventually cause future budget deficits to become unsustainable."
A better read may be Orszag's November report, The Long-Term Outlook for Health Care Spending.
A study in a recent issue of the Archives of Internal Medicine tracked use of the prostate specific antigen (PSA) test for prostate cancer between 1995 and 2004. It concluded: "despite the lack of clear evidence of benefit, PSA testing for prostate cancer screening has increased dramatically, especially among black men and younger men."
This week, a letter to the BMJ (subscription required for full text) from two French physicians reacts to a recent report on the feasibility of PSA testing in men ages 45-49. They write:
"Screening for prostate cancer in men older than 50 is hardly acceptable because overdiagnosis is obvious and the impact on mortality remains unproved despite the findings of numerous trials in the past 15 years.Of 19 major medical organisations worldwide, only the American Cancer Society and the French and American urological associations recommend screening men for prostate cancer with annual measurement of prostate specific antigen (PSA). Therefore, in addition to wasting resources, the paper by Lane et al will be used to promote screening. In France 36% of men underwent prostate cancer screening (unproved and not organised), whereas only 25% underwent colorectal cancer screening (proved benefit on mortality and organised). The only demonstrated effect of prostate cancer screening is a 5-10% biopsy rate in the screened population, with a risk of septicaemia and haemorrhage. Plus, for those treated, various adverse effects (impotence, incontinence, pain, rectal ulcers, etc)."
In what one physician calls a "deplorable" move that may be "a sign of desperation," Johnson & Johnson's Cordis unit has begun a direct-to-consumer ad campaign to promote its Cypher coronary artery stents.
You can read more in the New York Times, or read some bloggers' reactions here.
So picture one of these scenarios:
• during a televised football game (where the first ad appeared), a guy sorts through all the ad messages about erectile dysfunction, restless leg syndrome, sleep problems, and now coronary artery stents and decides to ask his physician on the next visit if a stent is right for him.• on the cath lab table, after an arteriogram demonstrates his coronary artery blockage, a guy sits up and says, "OK, then. Go ahead with the stent. But be sure it's a Cypher!"
News coverage has already begun for a newly-named disorder that has a handy acronym for a name and - lo and behold - has a drug ready to treat it.
It's called PGAD or persistent genital arousal disorder and Paxil has been mentioned as a treatment.
Blogger John Mack writes that "GlaxoSmithKline, which makes and markets Paxil, is the same company that brought us Requip for RLS! Coincidence? I think not!" And Mack, in his blog entry headlined, "PGAD. EGAD! Another Syndrome/Disorder, Whatever!" offers a storyboard for the TV drug ad he envisions for Paxil for PGAD.
Shannon Brownlee, in the December 2007 issue of The Atlantic Monthly (subscription required for full text) writes about what she calls "the health care crisis no candidate is addressing." She posits that we may have too many doctors in this country. Excerpts:
"Some experts would even go so far as to suggest we need fewer doctors, not more. Elliott Fisher, a physician and researcher at the Center for Evaluative Clinical Sciences at Dartmouth Medical School, quipped at a recent gathering at the Institute of Medicine, "If we sent 30 percent of the doctors in this country to Africa, we might raise the level of health on both continents." ...As for the rising number of physicians being trained, the remedy is simple: Turn the spigot back off, or at least close it part way. The groups now calling for more physicians should come up with better evidence that all those new doctors are not going to simply drive up costs."
Last week Niko Karvounis, on the Health Beat blog reported on the CDC's "landmark, and in many ways devastating, report on health care in the U.S." Niko lists some of what he calls "the myths that the report demolishes":
Myth: If people don’t have health insurance or get medical care, it’s because they don’t want it.Myth: The American system relies mostly, if not exclusively, on private enterprise to support health care.
Myth: East coast liberals and the urban poor are the only ones who want a stronger public sector in health care.
Myth: America has the most and best medical technology of any country in the world, and by God we should use it!
Item 1 in today's news:
Former UnitedHealth CEO Bill McGuire finally settled with the Securities and Exchange Commission over his stock options scandal. In all, he pays back $618 million. But don't lose sight of the fact he still holds options that are valued at $1.8 billion.
Item 2 in today's news:
A former department head fired from the Cleveland Clinic claims there are pervasive conflicts of interest at the world-renowned hospital. The Wall Street Journal reports the former head of the clnic's vascular intervention unit (a big bucks operation),
"said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients. ... His suit alleges the clinic has been "indifferent" to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos "Toby" Cosgrove, according to the complaint. The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring."
Some have called the issues of conflict of interest in patient care "a ticking time bomb" in health care.
In his regular e-mail newsletter and commentary, former U.S. Senator David Durenberger writes:
FDA approval of Abbott Lab's new drug-coated stent called Xience means there will now be four large corporate competitors in a relatively small field selling Taxus from Boston Scientific, Cypher from J and J, Endeavor from Medtronic, and a version of the Xience stent called Promus from Boston Scientific (with a drug coating different from Taxus). Multiply those products by thousands of sales persons in the cardiac market and the answer is a gradual expansion of the now $2 billion a year market for stents in this country. Since insurance payments go to hospitals who have financial incentives to encourage the heart surgery in which the stent is implaced, and surgical fees to surgeons who do them, the definition of "medical necessity" is determined by the surgeon's judgment and by the device supply market, not necessarily by the appropriateness nor by the cost-effectiveness of a particular surgery or stent.
The FDA has been criticized for how many scientists with conflicts of interest that the agency allows to serve on its advisory committees. The FDA says it can't find conflict-free experts. But a study by the Integrity in Science Watch project of the Center for Science in the Public Interest (CSPI) suggests the FDA isn't looking hard enough.
CSPI reports:
"For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. ... Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."
CSPI, along with other prominent science and consumer groups, urged the FDA "to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."
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Meantime, read Maggie Mahar's blog for details on the FDA Science Board report, "FDA: Science and Mission At Risk." Some lowlights:
* “The Information Technology situation is problematic at best—and at worst it is dangerous.”
* “The FDA has substantial recruitment and retention issues”.
* “Critical data…including valuable clinical trial data...are sequestered in piles and piles of paper documents in large warehouses."
* “The FDA has an inadequate and ineffective program for scientist performance."
* "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."
The Wall Street Journal's Health Blog recently had an item that suggests that drug companies' use of ghostwriters to promote positive findings and to not ask tough questions is alive and well.
The Wall Street Journal reports on "a slew of new cleaning products aimed at germ-phobic homeowners."
Much of it plays on the fears consumers may have over E. coli or MRSA.
The story describes products using silver ions, copper oxide, steam, triclosan or ultraviolet light to kill bugs.
Wow. I like soap.
Nothing new here at all - just the latest episode of a local community discovering that its glorified local health news is often just paid-for advertising.
The Other Paper of Columbus, Ohio unveils how Ohio State University Medical Center pays one station almost $100,000 a year to air "Breakthroughs in Medicine" segments in the newscast, and pays another station almost $150,000 for a "MedBreaks" segment.
The VP and general manager of one of these stations rejected criticism saying, “They’re not ads, they’re vignettes. ...The reality is, a television station that maintains editorial control I don’t believe is doing anything ethically wrong.”
OK, then why doesn't the station tell viewers what they're getting by scrolling across the screen:
THIS VIGNETTE WAS PAID FOR BY OHIO STATE UNIVERSITY MEDICAL CENTER.
The Radio-Television News Directors Association’s (RTNDA) Code of Ethics states:
Professional electronic journalists should:* Gather and report news without fear or favor, and vigorously resist undue influence from any outside forces, including advertisers, sources, story subjects, powerful individuals, and special interest groups.
* Resist those who would seek to buy or politically influence news content or who would seek to intimidate those who gather and disseminate the news.
* Determine news content solely through editorial judgment and not as the result of outside influence.
* Resist any self-interest or peer pressure that might erode journalistic duty and service to the public.
* Recognize that sponsorship of the news will not be used in any way to determine, restrict, or manipulate content.
* Refuse to allow the interests of ownership or management to influence news judgment and content inappropriately.
As we said at the top, this is nothing new. Columbus residents join the long list of television audiences all over the country who have been spoonfed one-sided PR and advertising messages from medical centers paying their way into newscasts. The fact that a supposed "news" organization would accept these deals is an embarrassment to the TV news industry.
When will RTNDA do something about it?
Many health policy observers are concerned about the impact of drug company promotion of "off-label uses" - unapproved or new uses of drugs that were approved for another primary use.
The FDA is now drafting guidelines on promotion of off-label uses, but the draft concerns Senator Henry Waxman, as Ed Silverman explains on his Pharmalot blog. Excerpt:
Waxman is concerned the agency is opening what he calls an “ill-advised guidance” and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.”